By now you are probably aware of the changes made to USP <661> in 2016 and the addition of USP <661.1> and USP <661.2> this year. In short, these changes required more in-depth analytical investigations on plastic packaging and materials. They also demonstrate how the USP is leading the charge to ensure polymer materials do not impact human health regardless of how or when those materials come in contact with a pharmaceutical product.

Additional guidance under development includes the new USP general chapter <665> (formerly <661.3>) titled “Polymeric Components and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products”, which recently finished receiving comments. It is accompanied by informational chapter <1665> “Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products”. <665> and <1665> are expected to be posted by February 2018 and will become official on August 1, 2018.

This new chapter emphasizes analysis of organic extractables and extractable metals on plastic manufacturing materials and components that assist in converting raw material into APIs, drug substances, and drug products. The polymers used in these manufacturing systems may contain additives of concern such as antioxidants, stabilizers, lubricants, plasticizers, and colorants. Once implemented, the new testing could encompass anything involved in solution transfer and transport, mixing and reacting, storage, and processing including:

Tubing and connectors

Tank liners and mixing bags

Raw material containers

Production reagents

Filters and chromatography columns

With the increasing influence of the USP on polymers in the pharmaceutical industry, new chapters, and frequent changes, it can be difficult to stay up-to-date with the latest recommendations. Fortunately, EKG Labs takes pride in keeping up-to-date with the latest USP revisions and is able to provide appropriate consulting and analytical services for companies seeking to conform to USP standards. Our team understands the complex interactions between pharmaceutical products and polymers, and we have years of experience guiding companies through the analytical portion of their product development.